Glossary

Quality Assurance

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What is quality assurance?

Quality assurance is the practice of designing, documenting, and improving the system that helps work meet requirements consistently. Quality control checks a specific output; QA focuses on the process that makes acceptable outputs repeatable.¹

QA asks why a process allowed a mistake and what should change so that failure is less likely next time.

What quality assurance includes

A QA system may include process design, SOPs, training, document control, internal audits, supplier controls, change control, nonconformance handling, corrective actions, metrics, and management review.

Quality assurance is a repeatable operating loop of process design, procedures, training, controls, audits, and corrective action. — Quality assurance turns requirements into a repeatable operating loop.

Quality assurance vs. quality control

Area	Quality assurance	Quality control
Core question	Is the process designed to produce acceptable work?	Did this specific output meet the requirement?
Orientation	Preventive and system-focused	Detective and output-focused
Typical work	SOPs, training, audits, change review	Inspection, testing, sampling, review

QA reduces the chance of defects. QC catches defects that still happen. Choosing only one creates predictable trouble.

QA designs the process while QC checks a specific output. — QA designs the process so acceptable work is repeatable; QC checks the output.

What quality assurance should document

Process ownership and approved procedures
Training expectations and change controls
Audit or review cadence and captured evidence
A corrective-action path for recurring or serious problems

Good QA documentation should make the system usable, not merely auditable.³

Quality documentation keeps ownership, procedures, training, change control, review, and corrective action close to real work. — Useful QA documentation keeps controls close to actual work.

AI-ready QA diagnostic prompt

Quality assurance diagnostic promptmarkdown

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## Quality assurance diagnostic prompt

**Glossary term:** Quality Assurance
**Source:** Trails Glossary — trails.so/glossary/quality-assurance

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### 01. Prompt

"Review the quality assurance system for [process/team]. Identify where work relies on memory, requirements are not translated into procedures, records prove the process was followed, QA and QC responsibilities are unclear, and recurring issues should trigger training, SOP changes, or corrective action."

How Trails helps

Trails helps process owners capture real workflows, turn them into step-by-step documentation, and create AI-narrated videos for training. That makes procedures easier to follow and maintain.

Related terms

Sources

1
ISO. ISO 9001:2015 Quality management systems. www.iso.org/standard/62085.html. Accessed July 15, 2026.
2
ISO. ISO 19011:2026 Guidelines for auditing management systems. www.iso.org/standard/70017.html. Accessed July 15, 2026.
3
ISO. ISO documented information guidance. www.iso.org/iso/documented_information.pdf. Accessed July 15, 2026.
4
FDA. Quality Management System Regulation. www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr. Accessed July 15, 2026.